READY! for Regulatory Affairs

READY! is a complete Regulated Information Management System (RIMS).

It provides a regulatory database and tracking of daily activities for your Regulatory Affairs Department.

READY! focuses on the most efficient way to plan, track, and monitor all regulatory activities and tasks.

Reminders and alerts help users focus on their daily work, never missing any deadlines.
All information is interconnected through hyperlinks, so it’s very easy to jump from a product to a variation or submission.

What is READY! for Regulatory Affairs?

  • ISO IDMP medicinal product database
  • Regulatory tracking system
  • Planning and project management tool
  • Searching and reporting tool
  • Electronic archive of documents
  • Electronic archive of submissions (sequences)
  • Time and cost tracking tool

READY! will enable you to update product information, manage your regulatory activities, and prepare comprehensive reports.

All regulatory information (products, activities, submissions, tasks, projects, and regulatory documents) is available within seconds on your computer or mobile device.

 

Reports

We have devoted significant efforts into providing comprehensive search and reporting capabilities.

READY! helps you quickly find information – like what is registered where and the status of each product, activity, and document.

For example:

  • An overview of Product Information (SmPC, PIL, labelling) per product and country with defined regulatory statuses
  • An overview of current labelling in the packs on the market (per product and country)
  • An overview of all planned, active, and finished RA activities (new MAA, variations, renewals, etc.)

Time tracking

Some companies want to collect data about how much time they spend on regulatory activities to plan more efficiently. Others need this information to bill their services to customers.

You will be able to track and plan the time spent for each of your products, or simply find out how much time you need per variation on average. This is meant for service providers preparing monthly reports for their customers, and so billing will be much faster and more efficient.

 

What-is-READY

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